L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH

Last updated: March 8, 2023
Sponsor: Beijing Friendship Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lymphoma

Bone Marrow Disorder

Red Blood Cell Disorders

Treatment

N/A

Clinical Study ID

NCT05775705
BFH20220920001
  • Ages 18-65
  • All Genders

Study Summary

The efficacy and safety of L-DEP (PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) regimen combined with PD-1 Antibody an induction therapy for Epstein-Barr virus (EBV)-positive lymphoma-associated hemophagocytic lymphohistiocytosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
  • EBV-DNA in peripheral blood > 1000 copies/ml or EBER detected in tissue specimens.
  • Age 18~65,gender is not limited.
  • Estimated survival time ≥ 1 month.
  • Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestivetract, lung, brain, etc.); If the patient has dyspnea, oxygenation index >250.
  • Signed informed consent.

Exclusion

Exclusion Criteria:

  • Heart function above grade II (NYHA).
  • Severe myocardial injury:TNT、TNI、CK-MB > 3 ULN.
  • Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicinabove 800mg/m2 or the patients treated with anthracycline induced cardiovasculardisease.
  • Pregnancy or lactating Women.
  • Allergic to pegylated liposomal doxorubicin,etoposide,or PD-1 antibody.
  • Thyroid dysfunction.
  • HIV antibody positivity.
  • Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable),acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibodypositivity, HCV RNA negative acceptable).
  • Participate in other clinical research at the same time.
  • The researchers considered that patients are not suitable for the study.

Study Design

Total Participants: 25
Study Start date:
August 01, 2023
Estimated Completion Date:
October 01, 2026

Study Description

Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Without early intervention, the median survival time is less than 2 months. Currently, HLH-94 or HLH-04 are the standard HLH treatment regimens, which have improved the disease response rate to approximately 70% and increased the 5-year OS rate to 50%. However, approximately, 30% of the patients remain unresponsive to standard therapy, especially if HLH is lymphoma-associated. Therefore, we conduct a prospective clinical study to explore the efficacy and safety of L-DEP (PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) regimen combined with PD-1 Antibody an induction therapy for Epstein-Barr virus (EBV)-positive lymphoma-associated hemophagocytic lymphohistiocytosis.

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.